Day Seven Huskey v Ethicon – Defense Experts Hail TVT

Day Seven Huskey v Ethicon – Defense Experts Hail TVT

Dr. Christina Pramudji, female urologist, Houston

This Day 7 of the Huskey v. Ethicon trial was a defense case with glowing reviews of the synthetic mid urethral sling.

Mrs. Huskey was implanted with a TVT-O made by Ethicon (J&J) in February 2011. The defense is wrapping up its version of events after the plaintiffs case which began last week. The plaintiff must prove, by the preponderance of the evidence, that the TVT-O family of polypropylene meshes is defective in its design, its manufacture and its instructions for use. The burden of pr0of falls on the plaintiff.

Before the case goes to the jury, expected this week, both sides will have another chance to speak to the jury in closing arguments.

This coverage is provided in conjunction with We Are Mesh Survivors, a coalition of synthetic vaginal mesh implant survivors united to demand justice for those who have suffered and to demand that existing products be pulled from the market until their safety can be demonstrated.

The first witness for the defense today was Dr. Elizabeth Mueller from Loyola, Illinois. Portions of her deposition were read by a different woman on the stand. See Dr. Mueller’s Expert Report here. .

Dr. Mueller had examined Jo Huskey. She was referred by Dr. Gretchen Byrkit, who had implanted a TVT-O (transvaginal tape obturator) made by Ethicon in Mrs. Huskey in February 2011. After several months, Mrs. Huskey had pain and was referred to two doctors, both of whom perform partial mesh removals.

She was then referred to Dr. Elizabeth Mueller in May of 2013. Many women spent time invested in seeking out multiple doctors to find a remedy to their pain following a pelvic mesh implant.

She is a board certified urologist with a sub-specialty board certification in Pelvic Floor Medicine and Reconstructive Surgery. She performed a recent physical exam on Mrs. Huskey to supplement her expert report, dated March 21, 2014. Dr. Pramudji says she’s done over 900 sling procedures.

She believes SUI can be related with lifestyle changes and surgery and that the polypropylene slings, TVT and TVT-O have a better outcome than a burch (suture) or native tissue slings.

“Polypropylene mesh has been used for decades. TVT and TVT-O are safe and effective surgical options for the treatment of SUI in women like Mrs. Huskey,” she said on the stand.

The urologist calls them the Gold Standard in her 49-page expert report and points to respected medical societies as echoing her beliefs such as the American Urogynecolgic Association, Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction, and the International Continence Society.

She says more than three million midurethral slings ( TVT, TVT-O) have been placed worldwide and they are used by 95 percent of the members of AUGS. See the afternoon story to continue the testimony of Dr. Pramudji.

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I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.

What intent would the manufacturer and physician societal collective sever but to promote, support and then sustain their financial gains from physician mesh use?

Don’t ask a barber if you need a haircut; don’t ask a surgeon “out in the trenches” making his/her living upon indiscriminate mesh abuse if you need a mesh…of course that surgeon would promote the benefits of non-restrictive mesh abuse (as it is ingrained in their nature too).

If you were to keep a credentials score card of both education and experience of expert witnesses and depositions, the plaintiff should always win these cases. Unfortunately as in politics truth doesn’t matter and neither does education and experience. I have read about urologists under oath testifying against specialist doctors with PhD’s in their field of pathology and molecular science. Is anyone listening to this testimony from day to day and case to case? There are so many contradictions and out right lies being told yet Ethicon keeps smelling like a rose. Judge Goodwin removed the possibility of punitive damages from this case. I believe the jury will find the product is defective by the shear volume of plaintiffs, physical evidence, highly credentialed expert witnesses and all of the contradictions that are so well documented. I am going out on a limb here and say that this will be a win for the plaintiff because there is just too much evidence and too many women.

Unfortunately, the number of lawsuits is one of the many things that are not allowed to be mentioned or considered along with the FDA warnings, clearance process, product MSDS, and more. There is more disallowed than allowed. Amazing.

Dr. Christina Pramudji has done over 900 sling procedures of the “Gold Standard” in her deposition. Her mentor Dr. Melvin A. Anhalt helped her on many of them and he has done over 600 slings to date with only one implant having problems which he quickly addressed. The only problem is during trial the plaintiff attorney showed a long list of women that Dr. Anhalt did not recognize that were suing Ethicon and Johnson & Johnson for problems with their mesh implants installed by Dr. Anhalt. Seven hundred dollars per hour has Dr. Pramudji on the tour circuit for Johnson & Johnson. Dr. Pramudji, how many names of your patients with mesh complications are on a list waiting to be seen? Do you remember what Dr Kirkemo said in his deposition?

“I don’t think I’ve ever seen a patient have dyspareunia from a retropublic sling,” he testified under oath.

Later he added “dyapareunia is part of all surgical procedures.”

Dr. Kirkemo was asked if he ever reach the conclusion that the mesh was defective.

“I mostly found it was the physicians’ fault,” he said in explanation of the adverse events.

A: “Yes I do there are tremendous amounts of physicians in love with TVT-O and in their hands they have success with low morbidity. If you have something working well for you you stick with it.”

Documents presented to Dr. Kirkemo showed he was a big fan of the Scion. It was “beautifully designed” he wrote and would solve the problems of the leg and nerve pain caused by the TVT-O where large needles pass through the obturator muscle potentially damaging nerves and muscles and causing permanent pain.

“You write, positioning can produce both orthopedic and neurologic injury and bone and nerve injuries you describe? “Yes. If done incorrectly, you can still have leg pain, groin pain, hip pain… you can have pain.”

Interestingly, the IFU for the Abbrevo mesh, which was eventually marketed, shows how to position a patient on the table, something Dr. Kirkemo admitted is missing from today’s TVT-O instructions for use. “It incorporates updates I thought were important,” he said referring to Abrevo IFU

The above statements are proof of defective design. Large needles pass through obturator muscle potentially damaging nerves and causing permanent pain. Dr. Kirkemo tells the truth when he promotes new products.

Anchors of the mesh device pass through the obturator muscle? How could anyone believe this is the best procedure and would not cause chronic pain…HELLO!

aha the mention of the AUGS!! every member there without arms length from mesh manufacturers should have their expertise disallowed !! so much truth is disallowed, it seems just to ask for opinions influenced by benefit from manufacturers to be disallowed ……

There are “physicians” who perform implant surgeries that also attempt explants of these PERMANENT devices. To my knowledge there is no training available for an explant of a permanent implant. If these surgeons attempting explants, (without proper training) are unable to remove 100% of the implanted device, are they not doing more harm than good? And as far as AUGS is concerned I would like to see them produce proof of their research and testing on humans that proves without a doubt that mesh is safe, or they should be discredited!

In fact, the AUGS “Position Statement on Mesh Midurethral Slings (MUS) for Stress Urinary Incontinence” and “FAQ for Providers” completely fail to include the term “risk” or “infection”. While “Complications” is omitted from the position statement, there is use of the phrase “difficulties and complications” in one sentence of the FAQ for Providers.

They have taken snippets from the 2013 FDA statement to benefit their cause. The link to the FDA statement from the AUGS statement is dead. That FDA page was updated in March 2014.

I noticed that the FDA has not reviewed Medical Device Reports (MDRs) since 2011. Because this is the FDA method for “detection of potential product-related safety issues as well as the benefit-risk assessments”, then it could be assumed that their statements on safety are badly outdated and they have not actively investigated mesh for SUI since 2011. They have relied on “self-reports” and “studies” from manufacturers.

I suggest all these companies that were involved be given 30 days to address every outstanding case in an equitable fashion.recourse would require they meet the deadline or forfeit their right to bring to market any new medical devices until every one of these cases is resolved and acknowledged, and apologized to. Does anyone here keep a registry of the mesh injured. I’m sick and tired of being treated like a subhuman. I’m fighting hard to maintain my balance between survivor and just plain pissed off. This is medical, insurance,and our FDA, treating everyone of us as collateral damage.